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Surgical Gowns

by GRI Medical & Electronic Technology Co., Ltd. EUDAMEDGUDID

Active European Union

Ref S90-3520

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number16931918153704 UDI-DIDate29 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69319181F002KM Basic UDI-DIDate16 Oct 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Alleset
Generic Name
Surgical gown, single-use
Device Name
Surgical Gowns
Model / Reference
S90-3520
Primary DI / UDI-DI
16931918153704
Basic UDI-DI
69319181F002KM
510(k) Number
FDA Product Code
FYA
EMDN Code
T020401 Standard surgical gowns
GMDN Term
Surgical gown, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4040
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000004203
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from GRI Medical & Electronic Technology Co., Ltd.

See all devices from GRI Medical & Electronic Technology Co., Ltd. →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No